Purpose

This is an international, multi-center, open-label, phase II study in patients with
metastatic urothelial cancer after failure of platinum-based regimen or anti-PD-1 /PD-L1
based immunotherapy.
At least 201 patients are anticipated to be enrolled across approximately 40 sites from North
America and Europe.

Eligibility

Inclusion Criteria

Cohort 1: Have had progression or recurrence of urothelial cancer following receipt of
platinum-containing regimen (cisplatin or carboplatin):

Received a first-line platinum-containing regimen in the metastatic setting or
for inoperable locally advanced disease;

Or received neo/adjuvant platinum-containing therapy for localized
muscle-invasive urothelial cancer, with recurrence/progression ≤12 months
following completion of therapy.

Cohort 1: In addition to above criterion, have had progression or recurrence of
urothelial cancer following receipt of an anti-PD-1 /PD-L1 therapy.

Cohort 2: Were ineligible for platinum-based therapy for first line metastatic disease
and have had progression or recurrence of urothelial cancer after a first-line therapy
for metastatic disease with anti-PD-1/PD-L1 therapy. Subject may not have received any
platinum for treatment of recurrent, metastatic or advanced disease.

Cohort 3: Progression or recurrence of UC following a platinum containing regimen in
the metastatic setting, or progression or recurrence of UC within 12 months of
completion of platinum-based therapy as neoadjuvant or adjuvant therapy.

Adequate renal and hepatic function.

Adequate hematologic parameters without transfusional support.

Creatinine clearance ≥30mL/min as calculated by the Cockroft-Gault formula.

Subjects must have a 3-month life expectancy.

Have measurable disease by CT or MRI as per RECIST 1.1 criteria.

Exclusion Criteria

Women who are pregnant or lactating.

Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study
Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events
due to agents administered more than 4 weeks earlier.

Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy
within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at
baseline) from adverse events due to a previously administered agent.

Cohort 3: Has active autoimmune disease requiring systemic treatment with steroids or
other immunosuppressive agent or any condition that in the Investigator's judgment
precludes treatment with pembrolizumab

Cohort 3: Has received a live vaccine within 30 days prior to the first dose of study
drug(s)

Cohort 3: Has history or evidence of interstitial lung disease (ILD) or non-infectious
pneumonitis

Cohort 3: Has received anti-PD-1/PD-L1 therapy previously

Study Design

Phase

Phase 2

Study Type

Interventional

Allocation

Non-Randomized

Intervention Model

Parallel Assignment

Primary Purpose

Treatment

Masking

None (Open Label)

Arm Groups

Arm

Description

Assigned Intervention

ExperimentalCohort 1 and Cohort 2

All subjects will receive sacituzumab govitecan (IMMU-132) 10 mg/kg intravenously on Days 1 and 8 of a 21 day cycle.
Cohort 1: Subjects with urothelial cancers, after platinum-based regimen (cisplatin or carboplatin) and anti-PD-1/anti-PD-L1 based therapy.
Cohort 2: Subjects in second line therapy of urothelial cancers, ineligible for platinum-based therapy and anti-PD-1/anti-PD-L1 based therapies failure.

Drug: Sacituzumab govitecan
All subjects will receive sacituzumab govitecan (IMMU-132) 10 mg/kg intravenously on Days 1 and 8 of a 21 day cycle.
Other names:

IMMU-132

ExperimentalCohort 3

All subjects in Cohort 3 will receive sacituzumab govitecan (IMMU-132) 10 mg/kg intravenously on Days 1 and 8 of a 21 day cycle followed by pembrolizumab at the standard approved dose (200 mg) only on Day 1 of a 21 day cycle.
Subjects who have had progression or recurrence of urothelial cancer following a platinum-containing regimen in the metastatic setting, or progression or recurrence of urothelial cancer within 12 months of completion of platinum-based therapy as neoadjuvant or adjuvant therapy.

Combination Product: Sacituzumab govitecan and pembrolizumab
All subjects will first receive sacituzumab govitecan (IMMU-132) 10 mg/kg intravenously on Days 1 and 8 of a 21 day cycle followed by pembrolizumab at the standard approved dose (200 mg) only on Day 1 of a 21 day cycle.
Other names:

IMMU-132 and pembrolizumab

Recruiting Locations

University of Texas Health Science Center at San Antonio
San Antonio,
Texas
78229

Subjects will receive IMMU-132 10 mg/kg administered intravenously on Days 1 and 8 of a
21-day cycle to be continued in the absence of unacceptable toxicity or disease progression.
In Cohort 3, all subjects will first receive IMMU-132 on Days 1 and 8 of a 21-day cycle
followed by pembrolizumab at the standard approved dose (200 mg) only on Day 1 of a 21-day
cycle. After discontinuation of treatment, patients will have a 30-day safety follow-up after
last dose and then will be followed every 12 weeks for survival for a maximum of 2 years.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health).
The listing of studies provided is not certain to be all studies for which you might be eligible.
Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

This study (NCT03547973) was last processed and updated on 5/12/2020 by ClinicalTrials.gov.